Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?

Jul 27, 2016 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance. One example involves researchers at the Northwestern University Feinberg School of...

Research Study Involving Northwestern Medicine and Harvard Indicates that Telomeres Could Be the Next Biomarker Pathologists and Clinical Labs Use to Detect Cancer

Dec 11, 2015 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing

Researchers demonstrate that the length of blood telomeres may follow a specific pattern before cancer is detectable, which could lead to new diagnostic tests for detecting cancer in its early stages Pathologists and Clinical pathology laboratories could soon have another tool to aid in the early detection of cancer. New research findings indicate that telomeres could serve as biomarkers for cancer if the right testing is done at the right times. This study was conducted by Northwestern...
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